ML20198K118
| ML20198K118 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1996 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-083, AF70-1-83, NUDOCS 9801140324 | |
| Download: ML20198K118 (13) | |
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DRAFT 3/25/96
- Environmental Assessment j for The Use of C-14 Urea Breath Test 4
l Tri-Med Specialties, Inc. .
Charlottesville, Virginia
- U.S. Nuclear Regulatory Commission Off!ce of Nuclear Material Safety and Safeguards Medical, Academic, and Commercial Use Safety Branch l April 1996 jenareog%
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4 ENVIRONMENTAL , ASSESSMENT For l THE USE OF C 14 UREA BREATH TEST
- 1. Hackground The mcent discovery of and the pathogenic implication of //clicobactor pylori (1/. pylori) to antral gastritis and duodenal ulceration has caused a dramatic change in the understanding and treatment of peptic ulcer disease during the past decade. //. pylort is a spiral- or helical shapec gram-negative j bacterium, with 4 to 6 unipolar sheathed flagella. This bacterium normally inhabits the gastric mucous layer epithelium of human stomach and the gastric metaplastic epithehum in the duodenum and esophagus.11. pylorlis probably the most common cause of non autoimmune gastritis.
The proposed action is for the U.S. Nuclear Regulatory Commission (NRC) to prant Tri Med Sycialties,Inc. in Charlottesville, Virginia,its petition filed on August 23,1994 (Tn Med,1994). l This proposed action would be taken to allow, through rulemaking, the general licensing and/or exemption fmm licensing for commercial distribution by licensed pharmaceutical manufacturers of capsules containing i pCi of phannaceutical grade "C-urca to test for the presence of II. pylori. l This procedure is sased upon the fact that // pylori produces the enzyme urcase that is rarely l present in human cells and is capable of breaking down urea to ammonia and bicarbonate (Corley, i' et al,1995). ',
Urease ~
CO(Nil 2): + 2110 2 +11' 2 Nil / + llCO, Urea Ammonium Bicarbonate The llCO 3" enters the blood stream and can rapidly be exhaled through the lungs as CO,. Since the ndrainistered urea is manufactured with radioactive caAon (14C ), detected IdCO, in the patient breath is indicative of urcase presence. Corley, et al. (199M. pointed out that 14CO, is usually i detectable in the breath 5 minutes after administration with a p k excretion in 10 to 15 minutes (Peura, et al. ,1996). The urea breath test (UBT) using 14C is oruy positive if II, pylort infection i is present. It is ideally suited to follow treatment to confinn eradication of this specific bacterium.
Specifically, Tri Med Specialties, Inc. petition is to permit the distribution d the capsule containing 14CO, either separately or as part of a diagnostic kit which supplies to ;vrform the test. The manufacturing process calls for one pCi of the 14C-urea to be placed in a gelein capsule. After insertion of the 14C into the capsule which is inspected externally for any comamination. The capsule is then placed into a commemial blister pack and then scaled. The sealed package is then placed into another container which is also scaled. That package is then placed mto a shipping container that is approximately 15.2 cm by 15.21 cm by 5.1 cm (6"x6"x2").
The petitioner states that this test is currently being studied at four sites under an Investigation of
- New Drug (IND) application accepted by the U.S. Food and Drug Administration (FDA) and at other sites under approved research protocols. The data obtained from these tests regarding the ,
- fate and biological pathways pmvided the basis upon which to perform the dosimetric calculations and provide scenanos to estimate (using a bounding method approach) the possible exposure of
- members of the public, family, and others who are likely to come into contact with the test materials or patients who have taken the capsule. -
'this proposed procedure is a noninvasive method and positive only if active II, pylori infection is ;
. 1 3n5/96
4 present . This test , as approved by the FDA (Tri Med,1994), is ideally suited to follow treatment to confinn eradication of II. pylori and is to be used in lieu of the gastrointestinal endoscopy procedure which is an invasive test, more costly, and involves some risk to patients.
Tnt Pro:ocol:
Tri Med Specialties, Inc. (Tri-Med,1994) and Marshall, et al (1991) described the UBT for the diagnosis ofII. pylori. The preparation of the patient for this test includes fasting for 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> and assurance that no antibiotics or bismuth salts have been taken at least 4 weeks prior to tlm test. 'lhe !
gapsule is then swallowed with 30 ml of warrn water to help the capsule to dissolve and release of C-urea into the stomach . After 15 minutes, up sq 2 liters of breath sample will be exhaled into a collection bag and promptly mailed by priority mail to a specialized laboratory to count 14C radioactivity. Breath samples containing less than 30 disintegration's per minute (dpm) above background would be considered ilP'. Activities above one hundred dpm are considered ilP'. It has been reponed that the idC urca breath test has a high diagnostic accuracy, with a sensitivity and specificity of up to 98'k ( Marshall,1994 and Peura, et al ,1996).
- 2. Need for the Proposed Action The proposed rulemaking is to grant the Tri Med Specialties, Inc. petition to allow for the general licensmg and/or exemption for commercial distribution by licensed pharmaceutical manufacturers of the IdC-urea capsule from licensing. This would provide greater flexibility to test.for and monitor the presence of H. pylori in ulcer patients. Currently, these tests are limited 'to only few facilities licensed to mccive IdC. Licensing exemption for commercial distribution of IdC-urea capsule would allow most doctors to perform the UBT at a cost saving to patients. General licensing would limit the distribution of these capsules and kits to only licensed physicians.
It is clear that ensuring cradication of II. pylori infection and curing ulcers can have a direct benefits to the approximately new 500,000 new ulect patients seeking health care each year, and mor 'han a mil; ion hospitalizations each year (Fennerty, et al,1994). The new noninvasive test using IdC urea capsules, as proposed, by Tri-Med Specialties, Inc., has a ytential to eliminate the need for rnany gastroendoscopies perfonned to view the stomach and ducc enal ulcera and to obtain samples for the detection of Il Pylori in ulcer patients. Gastroendoscopics are expensive and uncomfortable to patiet and the general public. Eradication of II. pylori infection is associated with a marked decreast t the recurrence rate of ulcers. A quantitative relationship between the degree of II. pylori imation seems to be unnecessary, since any detectable infection will tw treated.
- 3. Environmental Impacts of the Granting the Petition The potentialimpacts associated with granting the Tri-Med Specialties, Inc pc. aon are limited to human health and environment as tg penain to distribution, storage, use, and disposal of materials containing small amounts of C. Impacts associated with the manufacture of the IdC-urea capsule se not included in this assessment, since the petitioner alr:ady has an NRC license to manufacture C-urea prnducts. The general pathways to thew two major receptors are presented in Figure 3.1 3.1 Pathways to Ilumans Radiation doses associated with the distribution and use of the idC-urea capsules are presented in this section.
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Figure 3.1. Diagram depleting the potential "C releases and pathways to the Environment and Humans
- 3.1.1 OccupationaLExposurcs In this Environmental Assessment, all workers involved in the administration of the IdC-orea capsules or analyses of patient samples are considered potential " occupational" workers . Also, a dose conversion factor of 0.025 mrem per pCi inhaled was used in calculating the dose values for exhaled "CO by patients. This fa
- tor was derived from the NRC's Annual Limit for intake (All) for inhaled "bO dose limit (NRC,g 1991). for adult radiation workers (2x10' pCi) and the 5,000 mrem regu 3.1.1.1 Routine &posures ofHealth Care %'orkers Conservative bounding analyses show that mutine doses (committed effective dose equivalent, CEDE) for health care workers are unlikely to exceed 0.7 nvem/ year, and that the potential risks are small relative to established standards and variations in natural background. Consenative assumptions used in this analysis included that the clinical worker works full-time (8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> / day, 2,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> / year), the worker would administer 4 tests per hour with all patients in a common room with a room air volume of 68 m' (2,400 ft'), 50% of patients are infected with II, pylori.,
and the "C in the exhaled breath of infected patient was instantly and completely mixed with the room air at the stmt of the hour with no air turnover during the hour for the duration of the tests were assumed. In addition, the analysis assumed that the room air was completely flushed only after each hour of testing, despite the fact that buildings require some minimum air tumover.
Based on several calculations (Gotchy et al,1996) potential concentration of "C in exhaled breath fmm a H. pylori positive patient was calculated to average about 0.0012 pCi/L (Peura, et al, 3 3/25/96
e 1996, and Cember,1987). Also, it was calculated that a total of atmut 0.8 pCi would le immediately released a the room for 4 patients treated each hour. Accordingly, the amount of "C inhaled hourlv by the health care worker at 20 timin. would be about 0.014 pCi and the total annual dose would be about 0.7 mrem . The collective dose for all 75 health care workers would be about 0.05 person-renVyear or less.
This conservative dose represents about a 50% increase of the small dose (almut 1 1.5 mrem / year) from naturally occurring ' C in the environment (NCRP,1985 and NCRP,1987b) and only about a 0.5% increase in the annual radiation dose (300 mrem) from naturally occurring radiation in the environment (NCRP,1987b). It is also less than half the additional effective dose equivalent that would te received from increased cosmic radiation during a coast to-coast flight on a jetliner Gying at 39,000 feet MSL (NCRP,1987a) and far below any regulatory limits for members of the public.
Accordingiv, the health impacts to health workers associated with routine exposure are exiccted to be negligible.
3.L1.2 Routine lhposures ofMeasurements Laboratory Workers This analysis addresses the potentialimpacts on analysts or other workers in laboratories involved m measuring exhaled "CO, in balkmn samples received from physicians, hospitals or clinics.
Conservative bounding analyses of routine radiation doses to workers in measurements latoratories are unlikely to exceed 0.0011 mrem / year. This determination was based on several conservative assumptions including that 50,000 samples are handled at each of the available 12 large lateratories annually,50% of patients are infected with H. pylori, and that a maximum of 1.0% of the 200 balk)ons received each day at each laboratory would leak all of their contents into the storage room where a workers was responsible for logging in each sample box as pan of the quality assurance program, Routine collect ve dose for the entire group of 12 laboratory workers would be about .00003 person rem / year.
This reg"ulatory analysis focuses on exposures of laboratory workers involved in measuring exhaled CO, in balken samples received from physicians, hospitals or clinics. For medical technicians handling patient samples in a measurements laboratory, there would be no expected doses from routine landling of undamaged samples (any unused breath from the balloon would be released into a hood and removed from the laboratory). For those instances where patient samples arrive damaged or leaking, the laboratory worker could receive a small exposure. These bounding doses are small fractions of the annual radioactive exposure from natural background, and would be expected to result in any significant occupational risks.
3.1.1.2 Maximum Collective Doses to Practitioners and occupational Workers The maximum annual collective dose for workers was calculated to be about 0.05 person rem which is twice as the 1 to 1.5 mrem / year annual collective doses for 75 workers from naturally occurring "C in the environment (hCRP,1985 and NCRP,1987b), and only about a 0.5%
inen:ase above the annual radiation dose (300 mrem) from naturally occurring radiation in the environment. The routine collective dose for the entire group of 12 laboratory workers in the U.S.
5 would be on the order of 1.2x10 person-rem / year.
As discussed in Safety Analysis, bounding accidents result in small individual doses to workers on the order of 0.00063 mrem. The actual risk associated with accidents would be even lower, since
- 1) ventilation would be necessary to remove smoke before a worker could remain in the room for such a long period of time (i.e., diluting the room air concentration), and 2) the risk is the product of the consequences and the probability of the accident occurnng. Because the probabilities of the accidents occurring are much less than the expected operating life of such facilities, when the dose consequences of the assumed accidents are multiplied by the probabilities of occurrence, the collective doses would be extremely small, and would not significantly add to the bounding 4 3/25/96 l
l
. I collective doses calculated for normal operations. For example, the expected collective dose to workers from such fires would be on the order of 8x10' person-rem / year (6.3x10' rem / accident x 12 persons x 10' accidents / year). Such accidents would not add significantly to collective doses from routine exposures.
Iloth bounding normal and accidental releases would result in an immeasurable increase in the 12
!aboratory worker's annual collective dose from naturally occurring "C which would result in about 0.012 - 0.018 person rem / year (about 1 1.5 mmm yr person year NCRP,1985).
Natural backgmund radiation would result in an annual col cetive dose to these workers of about 3.6 person rcrn per year.
3.1.1.2 Accidental &posures ofMeasurements Laboratory Workers Two scenarios have been evaluated in this Environmental Assessment. The postulated accidents and potential impacts are described below.
Skin &posure it is possible, although highly unlikely, that an accidental "C urea capsule could break and result in spilling some of its contents onto the skin of a worker. The rupture of "C-urea caasule during administration would lead to an exposure of the skin to "C urea powder and a radiation dose.
Accidental spilling of the entire contents of a "C-urea capsule onto the hands of a worker is also not expected to result in a skin dose in excess of 5.8 rnrad, or a radiation dose (CEDE) of 0.025 mrem through skin absorption. These exposures are small and far below any regulatory limits.
To evaluate the potentialimpact of such an accident, additional assumptions were adopted. These assumptions include that the worker would attempt to brush off some of this material, spreading it over the skin of hands and arms. After an hour, the worker was assumed to wash the material frorn the skin with soap and water. To bound the possible exposure, it is assumed that washing would occur after one hour and it is further assumed that 30% of the activity would remain on the skin after washing (Gotchy et al,1996). The remaining 30% is conservatively assumed to be absorbed into the body. The resultant skin dose and whole body dose from the spill are estimated to be almut 5.8 mrad and 0.029 mrem, respectively. The skin dose was estimated using the beta dose calculations as described in the NRC Safety Report (Gotchy et al,1996).
Intudation bposure Only in the case where a "C-urea capsule is accidentally ruptured would there be an opportunity for accidental exposure of the skin of a health care worker to "C-urea powder. Conservative bounding analyses show that it is unlikely any health care worker would receive a dose in excess of 0.0035 mrem from accidents resuhing in inhalation exposure associated with the storage or administration of "C-urea capsule.
One of the greatest sources of potential exposure of workers would be from accidental releases of "CO, resulting from a fire which might oxidize the entire stored inventory of the capsules.
According to the petition for exemption, the largest inventory of "C-urea capsules expected to be rrceived by any one unlicensed facility would be 150 (Tri-Med,1994). The fire was conservatively assumed to oxidize the entire contents of the "C-urea capsules, releasing "CO 2 into the administration area (68,000 L). The likelihood of a fire in the storage area was estimated to be on the order of 0.001/ year. This is a conservative assumption reflecting an assumed frequency of 4 4 fires in laboratory areas that ranged from 2x10 for office and storage areas, to lx10 for laboratory areas. Details on the dose calculations and assumptions, are provided in the NRC Safety Report (Gotchy et al,1996).
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Doses to anyone in the general public outside the administration area from the released activity would be much lower than the dose to the worker, since the scleased activity would be quickly mixed in outside air and concentrations a short distance from the point (s) of release would tw orders of magnitede lower than experienced inside the administration area. The release of 150 pCi of "CO, to the atmosphere would not represent a significant increase to the large inventory of naturally occurring "C already present there (= 3.8 x 10' Ci). All such doses are small fractions of the nonnal variations in background radiation, and would not be expected to cause any impact to workers or mernbers of the public.
3.1.2 Patient Exposurn 3.1.2.1 Routine Patient Exposures This diagnostic pmcedure using "C-urea emits low energy beta radiation, as compared to the low beta energy and low atomic number of the surrounding tissues. Therefore, there is no measurable source of extemal exposure from storage or casual handling of a number of the "C-urea capsules and the major concerns are mostly mlated to skin contamination or internal depositions following accidents.
Removal of "C urca from the stomach was assumed to follow three independent pathways corresponding to urea, bicarbonate /CO # , and a long term retention compartment of "C labeled moleculc4 (Tri Med,1996a). The detailed description of this process is given in the NRC's Safety Report for this proposed action (Gotchy, et al,1996). The calculated Effective Doso Equivalent (EDE)is 0.38 mrem /pCi for an llP~ individual and 0.18 nurm/pCi for an llP' individual. These calculated doses are simitr<; to those reported by Pippen (1996) who showed also that women may have a higher EDE value (0.48 mrenttCi). In addition, it was estimated that it would take approximately than 5 - 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for tie exhaled radioxtivity to be indistinguishable from background.
3.1.2.2 Collective Dmes to Patients in the U.S.
It is assumed that there will be a maximum of 600,000 annual administrations of capsules containing 1 pCi of "C-urca in the U.S. Using an average EDE of 0.3 mrem, the collective 30pulation dose would be about 180 person-rem per year. The collective annual dose from natural 3ackground radiation would be about 1.8x10' ocrson rem. Accordingly, these tests would only increase the annualcollective dose from natural background by atout 0.1% for one test or 0.2%
for two tests, respectively.
3.1.2.3 Misadministration Etposures ofPatients For the purposes of analysis, NRC assumes two potential consecutive administration were considered. A single dose administration to the wrong individual (assumed to be a pregnant woman who is llP~) and a multi >le dose misadministration. In the first scenario, the radiation dose to the woman would be t ne same as that received by a llP female, 0.48 mrem. The cumulative dose to the fetus from a 1 pCi intake by the mother under the assumptions defined below would be 1.29 miem. In the eve - ' hat a pregnant woman arceived multiple administratio=
of three capsules, the conservative dose to the fetus was calculated to be about 3.8 mrem.
In the second scenario,it was assumed that three doses are administered by mistake to a single latient. Another way in which a patient might get a multiple dose would be for the capsules to secome seFated from the blister pack and assumed to be analgesic medication, which would then be administered to a patient. The dose to an HP' individual ingesting three capsules would be about 1 A mrem.
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Given the low probability of such misadministrations, the expected dose would be much lower.
The maximum potential dose to the fetus is significantly below the maximum dose allowed to an embryo carried by a declared, pregnant radiation worker (NRC, 1991; 500 mrem, (( 20.1208),
and a pregnant woman would have to consume over 100 "C urea capsules in order for the fetus to receive that dose.
The likelihood of a pregnant woman experiencing ulcer disease and requiring such a test is small in comparison to the overall incidence of ulcer disease in the gmeral population. In 1992, there were 4,569,000 ulccrs in the United States population reported as requiring tmatment; the rate for women under 45 was 4.8/1000. This rate mercased to 27.8/1000 for women in the 45-64 age group. For women over 75, the rate was 75.5/1000. (DOC,1995). As a resnit, the probability of such exposures are less than estimated for the general population.
3.1.2.4 Accidental Enposures ofPatients This is bounded by the already small doses for workers respo, ding to a fire which is assumed to release the entire maximum inventory of capsules to the admmi:tration area. Since it was assumed that patients in a nearby waiting room would be evacuated when the fire ahirm went off, it is unlikely that patients would be exposed to such releases, and their doses would likely be zero.
Nevertheless,if the patients in waiting room were exposed during the evacuation to a concentration that was 10% of that to which the worker was exposed to, and for a limited 5 minute period, their doses would be less than 7x10$ rnrem or almut a 30th that of the worker. The dose to a patient from accidental rupture of a capsule during administration would be substantially less than from the direct intake, and would be the same as the accidental dose to a health care worker which is about 0.1 mrem. This potential impact and associated risks is considered to be small.
3,2 Pathways to the Environment The earth's atmosphere contains an inventory of naturally-occurring "C of about 3.8-million curies (equivalent to the activity in 3.8-trilhon breath tests), which in addition to the huge inventory of about 240-million curies in the world's oceans and ocean's floor (NCRP,1985). The "C released into the atmosphere would mix with the global inventory and expose the public and other biotic components of the environment to "C intakes from inhalation, drinking water, and all possible food pathways in the same manner as naturally-occurring "C. Since the current world mven:my of naturally-occurring "C results in an average dose to the public of about 1.25 mrem / year, release of 0.6 curies of "C from breath tests would result in an average annual dose of about 2x10 " mrem. In a total population of about 260-million peo? l e in the U.S., the collective annual dose would be about 0.051 person-rem, impacts associatect with any releases of "C to surrounding environmental media are expected to be very small due to the fact that the concentration of CO,relewd is very low and would be mixed in the atmosphere immediately.
Therefom, impacts associated with any releases of "C to surrounding environment are expected to be very small and expected risks are minimal 3.2.1 Collective Esposures to Members of the Public The small increases in doses from naturally-occurring "C are of little significance to human health and environment. Potential long term impacts from wide-spread releases of the long-lived "C 15,730 year radiological half-life) from breath tests was considered 16 insignificant. Assuming that the testing in the U.S. would Lcrease over a period of time to s scrage of a million tests per year for 50 years, the collective annual dose to the U.S. would be abou 5 person rem over the uext 50 yerirs. This dose is very small when compared to the anmnl ecdlective dose to the U.S.
population from naturally occurring "C of over 300,000 person rem, and about 78,000,000 person-rem from all naturallyacurring radiation. Clearly, an increase of a few person-rem will 7 3/25/96
not signincantly change those exposures, and there would be no expected impact from the widespread use of breath tests on the entire U.S. population over periods of decades. ,
Another potential source of public exposure could result from exhalation of "CO, by satients to a family member, co-workers, or member of the public. The collective annual dose wou d be on the order of 2.5 person rem which is expected to introduce very small impacts.
3.2.2 Disposal of"C Urea Capsules or Afaterials There are several disposal options associated with the proposed action and alternatives. The impacts of these disposal options are detailed below.
3.2.1.1 Disposalofoutdated Capsules Capsules which exceed the approved shelf life could be disposed of by either incineration or landfill burial. Disposal of a few capsules a year into a large volurne of typical waste from a commercial operation would result in effective concentrations that are far less than the 0.05 pCi/g level that NRC considers to be non-radioactive waste. The items may be disposed of without regard to radioactivity (10 CFR 6 20.2004,10 CFR 6 20.2005, and 10 CFR 6 20.306(a)) by an NRC licensee, through incineration or disposal in a landfill . Outdated capsules could also be retumed to the manufacturer for disposal through incineration along with other nuclear medicine wastes ( 10 CFR 6 20.2108). The disposal of 0.05 pCi/g wastes would not represent a significant increase to the large inventory of naturally occurring "C already present in the environment.
3.2.1.2 Disposal ofSample Collection Residues and Afaterials The materials used for collection of patient samples (balloons, etc.) are not expected to contain detectable radioactivity following their evacuation based on actual measurements of cut-up balk >ons fmm llP* patients by Tri Med (Tri Med,1996c), so these and related materials (e.g., collection tubes, etc.) should be disposed of in the same manner as other non hazardous mataials as stipulated in 10 CFR i 20. 2005.
3.2.1.3 DisposalofScintillation Fluid The average patient sample counted in liquid scintillation fluid is appmximately 0.00068 pCi for a given fluid volume of about 15 ml (Marshall et al,1991). The concentration would be about 3.8x10 5pCi/g. This is about three orders of magnitude below the NRC standards of 0.05 pCi of "C per gram which licensees may dispose of the material as non-radioactive waste (NRC,1991; (20.2005). Based on this estimate, it would appear licensees could treat this material as non-radioactive, and dispose of it as ordinary sanitary waste.
Ilowever, since the fluid contains toluene and xylene which are classified by the EPA as spent solvent hazardous wastes, their disposal in landfills could cause RCRA to be an Applicable and Relevant or Appmpriate Requirement (EPA,1991). Because cf these concems, the disposal methodology for the scintillation fluids should involve incineration. Due to the small amount that would be generated (approximately 60 liters) at each laboratory monthly, the generator re?orting requirement is not mandated by RCRA.These materials could easily be sent to a commercia waste incinerator for disposal; The total annual volume of liquid scintillation fluid for 600,000 samples per year would be about 9,000 L, and contain only about 410 pCi of "C. Atrnospheric dispersion following release fmm an incinerator stack would present no significant public exposures to "CO,.
The average concentration released fmm the incinerator stack is expected to be about 4.3x10*
- tCi/L annually. Conservatively assuming an adult is downwind at 100 m for an entire year, 4
breathing at a rate of 20 IJmin., the dose would be on the order of 1.2x10 mrem. Clearly, disposal of the entire annual production at a small incinerator would result in an inconsequential 8 '3/25/96
exposure of a member of the public. Exposures at more incinerators with each facility burning smaller quantities, a9d with the public typically further distant from a release point would be even lower.
Although not a viable disposal alternative to incineration, it is noted that for 600,000 patient samples (half from IIP' patients) produced per year, the total annual release from this source of "C would be about 410 pCi, which is far below the 6 20.2003 annual limit of ICi/ year for sewers at licensed facilities.
3.2.1. 4 Disposalof Contaminated Urine Urine from patients given breath tests contain small amounts of "C-urca; the amount will be largest for IIP ~ patients with almost all of the "C-urea excreted in urine (Tri Med,1996a). Voiding volume each day would be on the order of 1,400 ml/ day for ren and 1,000 ml/ day for women (ICRP,1975). Most of the "C-urea would be excreted in the first 5 days, with smaller amounts excreted over sescral additior.al weeks. If it were conservatively assumed that the entire intake 1.0 pCi were excreted during the first week, the bounding average concentration in the urine would be on the order of 1.2x10 pCi/ml which is already far below the monthly average concentration 4
(after dilution by the entire liquid volume of all sewer effluents of "C, 3x10 pCi/ml) allowed to be released to sanitary (NRC,1991). Accordingly, the release to sanitary sewers for llP~ patients would result in concentrations that would be orders of magnitude below that calculated for 11P" patients at licensed facilities such as hospitals. Such releases would be benign since they would not result in any impact to the public or the environment. .
3.2.2 Waste Minimization Disposal of scintillation media which is classified as hazardous waste should be separated from scintillation vials. Empty scintillation vials containing no more than background activity could be shipped to glass recycling facilities.
- 4. Alternatives to the Proposed Action The reasonable regulatory altemative, in addition to the No Action Altemative, considered in this Environmental Assessment is to grant a petition to allow distribution of "C-urea calsules. Then:
are several alternatives to test for H. pylori. These testing attemative methods can x categorized into invasive and noninvasive tests. -
4.1 Noninvasive Test Alternative Scrological tests for the detection of H. pylori are known to be highly sensitive, very specific, and low cost and very usefulin identifying patients with past exposure. These tests are based on the fact that H. pylori infection induces kcal and systemic immune response in the blood system.
Scrological tests, however, are not useful in accurately confirming H. pylori eradication nor to monitor the effects of the antibacterial therapy, because it takes several months for the induced immune response to dissipate.
4.2 invasive Test Alternatives
'Ihere are three invasive test alternatives to diagnose H. pylori in ulcer patients. following is a review of the alternatives.
4.2.1 Biopsy Urease Test This test is based on the ability of H. pylori to produce the enzyme urcase, hydrolyzing urea into 9 3/25/96
ammonia and bicarbonate. Tissue samples taken from stomach lining during endoscopy are ex msed to gel containing urea that would break down in the presence of urease and change the ge Fs color from yellow to pink in the presence of pil above 6. This test is excellent for initial diagnosis with endoscopy and easy to perfonn with rapid results.
4.2.2 llistology.
In this alternative, tissue sampling is taken during endoscopy to identify //. pylori by appearance with routine bematoxylin and cosin stained tissues. Special stains such as Giesma or Wanhin-Starry may be used. This test is considered the gold standard of these attematives and is used to assess the severity of gastritis and confirms the presence ofII. pylori. liistological test also serves as a permanent acord and is excellent for initial diagnosis with endoscopy.
4.2.3 Culture.
This attemative is extremely accurate in identifying II. pylori under clinical conditions. The test method provides the physicians the opportunity to conduct antibiotic sensitivity tests. The high degree of precision attained by such test is outweighed by the difficulty in culturing II. pylori in the laboratory.
The potential impacts and risks associated with the No Action alternative are not any different than the impacts and the risks to patients already existing. The costs to patients for the diagnoses confirmation of eradication of fl. pylori would be more difficult than the proposed action. The No Action would not, however, involve the exposure to "C.
- 5. Environmental Justice The analysis in this Environmental Assessment shows that there will be no significant imprt to the public and the environment from this proposed action. The NRC has committed itself to complying in all its actions with the pmsitential Executive Order # 12898 " Federal Actions to Address Environmental Justice in Ninority Populations and Low income Populations", dated February 11,1994. Therefore, the NRC also has determined that there are no disproportionate, high and adverse impacts on minority and low income populations. The NRC, on the other hand, found that granting the proposed action could be associated with health benefits to all populations including minority and low income wpulations, because it is the only noninvasive test that can accurately and rapidly confirm II. pylori total eradication at lower cost.
The NRC uses the following working definition of envimamental justice: envimnmental justice means the fair treatment and meaningful involvement of all people, regardless of race, ethnicity, culture, income or educational level with respect to the development, implementation and enforcement of environmental laws, regulations, policies.
- 6. Finding of No Significant impact This Envimnmental Assessment focuses on the potential bounding 2mpacts of routine storage, administration, and disposal of both capsules containing "C-urea and patient samples containing small fractions of the total "C admmistered for the breath test to detect the presence of flelicobacterpyloriba0. via in the human digestive system. It also evaluates the potential dose to patients (both IIP
- and tiP') receiving the capsules, and potential impacts on members of their families and the general public who may come into contact witl }{P' patients exhaling "CO2 following their breath tests. It also considers accidental exposures resulting from human error (including patient misadministrations and skin contamination of bealth care workers),
tnmsponation, and facility accidents such as fire (including exposure of a visiting lactating, 10 3/25/96
pregnant mothu and dose to the fetus). It is concluded that the potential impacts of the conservative bounding analyses support the conclusions that (1) the potential impxts associated with the use of the proposed "C-urea breath test are so small they are well within nonnal variations in natural background radiation;(2) they are below all regulatory limits and below the level which would require reporting to the EPA under the Clean Air Act (NESilAPS); and (3) any potential risks are small relative to the risks avoided (e.g., ulcers and cancer of the stomach and duodenum), and no individuals would be expected to experience any radiation related risks.
- 7. References Cember,11., Introduction to #calth Physic.7, Second Edition, Pergamon Press, Elmsford, NY, 1987.
Chey, W.D., M. Spybrook, S. Carpenter. T.T. Nostrant, G.l!. Elta, and J.M. Scheiman,
" Prolonged Effect of Omeprazole on the "C Urea Breath Test", Am. J. of Gastroentorology, Vol.
91, No.1, pp. 89-92, January 1996.
Corley, J., J Yoder, S. Raibon, and G. Burke," Nuclear Medicine's New Role in Peptic Ulcer Disease Management". Joumal of Nuclear Medicine Technology 23 (4), December 1995 DOC (Department of Commerce), Statistical Abstract of the United Statn, Jtem No. 215,115th ed., Department of Commerce, Economics and Statistics, Bureau of the Census,1995.
Environmental Protection Agency (EPA), letter ' rom Sylvia K. Lowrance, Director of the 1 PA Office of Solid Waste regarding " RCRA ARAR Determination at Maxey Flats Superfund Site",
U.S. Environmenta' Protection Agency, Washirigton, DC, September 4,1991.
Fennerty, M. B., T. P. Gage, L A. Laine, D. A. Peura, and D. T. Smoot, "Helicobacter pylo*! -
The New Factor in Management of Ulcer Disease," American Gastroenterological Association,Inc and American Gastroenterological Foundation, Inc., Bethesda, MD,1994 Gotchy, R. L., L. Battist, and R. Karimi Safety Report for the Use of C-14 Urea for the Detection of li, pylori Bacteria in the iluman Alimentary Tract, Prepared for the Us Nuclear Regulatory Commission, April 1996 (Draft).
International Commission on Radiological Protection (ICRP), Report of the Task Group on Reference Man, ICRP Report No. 23, Pergamon Press, Elmsford, NY,1975.
Lowrance, S. K., RCRA ARAR Determination at Maxey Flats Superfund Site, Memorandum from Director of EPA Office of Solid Waste,,, D. J. Guinyard, Director of Waste Management Division, EPA Region IV and Jol.n R. Barker, Regional Counsel for EPA Re,, ion IV, September, 04,1991.
Marshall, B. J., "#elicobacter pylori", The American Joumal of Gastroenterology 89 (8),1994.
Marshall, B.J., M.W. Plankey, S.R. lioffman, C.L. Boyd, li.F. Frierson, R.L Guerrant, and R.W. McCallum, "A 20-Minute Breath Test for Helicobackrer pylori", The Am. J. of Gastroenterology, Vol. 86, No. 4,438-445, April 1991.
NCRP (National Council on Radiation Protection and Measurements), Joni:ing Radiation Exposure of the Population of the United States, NCRP Report No. 93, Bethesda, MD,1987a l1 3/25/96
e NCRP (National Council on Radiation Protection and Measurements), Exposure of the Population of the United States and Canadafrom Natural Background Radiation, NCRP Report No. 94, Bethesda, MD,1987b.
NCRP (National Council on Radiation Protection and Measurements), Carbon 14 in the Environment, NCRP Report No. 81, Bethesda, MD.1985.
NRC (Nuclear Regulatory Commission), "Standardsfor Protection Against Radiation: Final Rule, 56 FR 23360", May 21,1991.
Peura, D.A., D.J. Pamianco, K.R. Dye, C. Lind, II.F. Frierson, S.R. Hoffmari, M.J. Combs, E. Guilfoyle, and B.J. Marshall, " Microdose "C-Urea Breath Test Offers Diagnosis of 11. Pylori in 10 Minutes", American Journal of Gastroenterology Vol. 91(2), February 1996.
Pippen,1996, letter report to Dr. R. L. Gotchy, SAIC, from Mr. Iloward Pippen, SAIC, February 26,1996.
Tri Med Specialties, Inc., " Letter to the Director, Freedom of Information and Publication Services, U.S. Nuclear Regulatory Commission", August 23,1994.
12 3/25/96
.l DRAFT 3/25/96 l
Analysis of Cost's and Benefits i for the Use of C-14 Urea Breath Test i
j I Tri-Med Specialties, Inc.
- Charlottesville, Virginia -
J U.S. Nuclear Regulatory Commission
, Office of Nuclear Material Safety and Safeguards Medical, Academic, and Commercial Use Safety Branch Apil 1993
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TASK 4.0 Preparation Of A Cost /Henefit Analysis
- l. INTRODUCTION:
The ICF/SAIC team was tasked as part of Task Order No. 4 " Petition for Rulernaking filed by :
Tri Med Specialties: Technical Aswcance for Rulemaking Support" to x. form an inc ependent re view of the information provided by the petitioner, and prepare a costhenefit analysis of three .
r egulatory altematives:
- 1. Granting the petition to allow distribution and medical use of the product under a general license:
- 2. Granting the petition to allow distribution and medical use by sxcmpting the product from i NRC regulatory control, ar.d
- 3. Denying the petition and licensing the distribution and medical use under specific license only.
Cmis -
In <>rder to accomplish this we analyzed the NRC costs associated with granting the petition. The costs associated with granting the petition include: ,
NRC Rulemaking Cost - This cost covers the cost of NRC time and of contractor time spent analyzing the merit of the Tri Med petition and developing all information needed to effect a rulemaking.
IIcalth and Safety Effects Cost - This cost, assessed at $~2000 per person-rem, reflects the impact to the total wpulation exposed to the radioisoiope that results from administration of the test by doctors wit tout licenses.
. Relatdhs The following benefik to NRC were considered in the analysis:
NRC Savings - These savings come from the license application fee and annual license maintenance fee. These fees cover NRC time and materials costs for processing and maintaining the license, if a license is not required, the NRC would realize cost savings.
(Note that allowance is not made for license amendment, et a fee ot' 5440, because it is assumed that a doctor applying for a license will tend to be a single practitioner interested in performing the test. It is assumed that the doctor would not likely face a license amendment situation. in cases where the doctor closed or otherwise changed his/her practicc, he/she would most likely choose to discontinue the test. Any doctor taking over the practice would file for a new license.
Patient Savings - If the Tri Med petition were granted, an internist or gastrointestinal specialist would be able to administer the test to a patient without an NRC license Thus, savmg the patient the time and expense of being referred to a licensed specialist, who would probably charge an administrative fee for reviewing the patient's health history and completing "new patient" paperwork prior to administering the test.
1 U - . - -. -.- -.
Referral to a licensed doctor would also raise the cost to Ar patient by adding the following incremental costs over those spent if the patient were a' : ' se his/her local doctor: (1) time
' cost of the travel, including food spent by the patient traveling to the referred doctor and (
and lodging.
Medical Feility Savings -If the Tri-Med petition were granted, the doctor would not have to complete paperwork for either license application or annual license maintenance. Thus, granting the petition will result in medical facility cost savings. The paperwork must be completed by the doctor because he/she is ultimately responsible for establishing and admmistering policies and procedures for the safe use of the test. Also, doctors likely to administer the test are assumed to be general practitioners; such practices do not have clinicians experiew 1in un of radioisotope-based tests, who would be qualified to complete some of the papere ;rk, potentially at a lower hourly rate.
- 2. ANALYSIS OF COSTS AND HENEFITS 2.1 Cost Aralysis NRC Rulemaking Cost The rulemaking cost is based on the cost of NRC effor*s at $50/ hour and the cost of the ICF/SAIC contract, bo6 fully loaded costs, '
r NRC cost: $50/ hour *0.5 FTE*2080 annual hours /FFE = $52,000 '
Value ofICF/SAIC Contract: $63,715 Total rulemaking cost: NRC cost + Value of ICF/S AIC Contract = $ 115,715 IIcalth and Safety Effects Cost The health and safety effects cost, assessed at $2,000 per person-rem, is $0 based on the following rationale, it is assumed that 600,000 test administrations will occur regardless of whether the Tri-Med petitlen is grmet or denied. A 180 penon-rem collective dose /600,000 annual test adminiwaiott 5 as been calculated.
The dose calculation included exposure scenarios equafly , pN able to all doctors, regardless of licensing status. The dose is independed # ar.y training a doctor would receive as a condition of Part 35 licensing. Therefore, there is no additional exposure that might result if Part 35 is amended to allow the test to be distributed to all doctors.
Total health and safety effects cost: $2,000 per person-rem *0 person-rem collective dose representi ng the higher dose !evel resulting from unlicensed doctors administering .he test = $0 Total Cost NRC Rulemaking Cort + Health and Safety Effects Cost = $115,715 2
2.2 Benefit Analysis NRC Savinga If the petition for exemption from Pan 35 licensing is granted, paties administering the test will not pay licensing fees. These fees reimburse the NRC for costs of maintaining the license; such costs would not be incurred if the test were distributed under a Part 35 exemption, resulting in savings to the NRC.
NRC Savings:
- One time fee: $1,400 NRC new license feel *6000 Unlicensed doctars seeking the testing privilege = $8.4 million
- Annual fee: ($4,300 annual Part 171 fec2)*6000 Unlicensed doctors seeking the testing privilege = $25.8 million/ year Patient Savings if the petition is granted, patients will receive the following benefits:
- 1. Travel and personal time - They will not have to ce mmute to a licensed facility that may not be local, resulting in travel expenses and in the cost of their travel time (e.g., sick leave or vacation). These costs are not addressed quantitatively in the following analysis because the distribution of patients across the U~nited States relative to licensed facilities is unknown.
- 2. Administrative costs - They will not have to pay additional administrative costs (e.g., duplicate medical histories) that might be required by the licensed facility recommended by their doctoc. Note that the administrative cost would be a one-time cost for a patient receiving more than one administration of the test at the same facility. These benefits would be received by all patients, since the local doctor could adm:nister the test. Therefore, the value of this benefit is:
Patient Savings:
- Administrative costs: $19 Medical processing costs / administration 3*600,0C') administrations / year = $11.4 million/ year INRC 9170.31 Item 7A.
2NRC 9171.16 Item 7A. This fee covers annual NRC expenses including inspections and license renewals.
3The medical processing cost has been calculated as the incremental cost of an office visit to a general family practice doctor by a new patient ($64.90 per visit) retailve to an established patient ($45.90 por visit). These data are froin American Medical Association, Physician Market Place Statistics,1995 edition, Table 40 and Table 39, respectively. General Family Practice is defined as excluding radiologists, 3
+
.x Medical Facility Savings A licensed facility must pay to maintain its license. . Costs are for labor and materials the facility spends to pre pare for NRC filings and inspections; they _do not include NRC license fees, whici cover NRC expenses. Currently unlicensed facilities that would provide the test under a Part 35 license exemption if the petition
' were granted would not have to bear such costs.
Medical Facility Savings:
- One time savings: $6,440 to $9,100 Cost of filing for license 4*6000 Unlicensed doctors seeking the tesdng privilege = $38.6 to $54.6 million
- Annual savings: $6,440 to $9,100 Cost of maintaining license 5*6000 Unlicensed doctors seeking the testing privilege = $38.6 to $54.6 million/ year Total Benefit One time: NRC Savings + Mcdical Facility Savmgs = $47 million to $63 million Annual: NRC Savings + Patient Savings + Medical Facility Savings ,= $75.8
- million to $91.8 million
- 3. CONCLUSION The analysis of costs and benefits indicates that the benefits, at $47 to $63 million for one time benefits and $75.8 to $91.8 million for annual benefits, are over 500 times greater than the rulemaking cost ($115,715). The high net benefit is a result of (1) absence of health and safety effects costs and (2) large benefits. Much of the benefit comes from savings related to the licensing process:
- One Time Benefits: Over 80 percent of these benefits go the doctors, who do not have to psychiatrists, anesthesio.ogists, and pathologists.
4 Based on 70 hours8.101852e-4 days <br />0.0194 hours <br />1.157407e-4 weeks <br />2.6635e-5 months <br /> at $92/ hour to $130/ hour. The low end of the range is based on
$45.90 per office visit charged by a general family practice physician. This statistic is cited in American Medical Association, Physician Market Place Statistics.1995 edition, Table 39, 11 a . visit is not more than 30~ minutes, the hourly rate would be approximately.$92. A telephone sampling of some general practice physician visit rates for the Washington, DC area indicates a rate of $65/ visit, with the visit lasting not more than 30 minutes. Such a rate is equivalent to $130 per hour.
5 Based on 70 hours8.101852e-4 days <br />0.0194 hours <br />1.157407e-4 weeks <br />2.6635e-5 months <br /> / year _ at $92/ hour to $130/ hour. See Footnote 4 for an explanation of the rates.
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s xnd time filing for an al,piication. The remaining percentage goes to the NRC, which c oes not have to spend time piocessing the filing.
Annual Benefits: The NRC realizes 28 to 34 percent of the total annual benefit of not requiring doctors to be licensed; medical facilities realize 51 to 59 percent of the total annual benent because they would not have to spend time preparing documents to mairtain the license on an annual basis. Together, NRC and medical facilities receive about 85% of the annual benefit.
Ultimately, the consumer realizes these benefits because the medical facility would not pass NRC fees and the cost of Gling for and maintaining an NRC license through to the consumer in the form of higher test fees.
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- February 22, 1996: l n ^i L The Honorable Jan~ Meyers' ;
-United States House of Representatives' -r L Washington, DC_-20515-
Dear Congresswoman Meyers:
-I,am responding ~to your letter dated January 16, 1996,- to the-Nuclear-Regulatory Commission'c (NRC's) Chairman regarding a petition for rulemaking, .l filed by Tri-Med Specialties, Inc. (Tri-Med). The NRC staff is actively :
working toward resolution of the petition. 1
?!'would like to point out that existing NRC regulations already permit the use' '
fof this' radioactive drug by physicians, to the extent permitted by the Food .
and Drug. Administration-(FDA), provided they are working under an NRC specific. .
L- Elicense-for medical use. Physicians who hold specific licenses from the NRC:
must meet basic training:and experience requirements regarding the safe use of '
radioactive drugs. Tri-Med's petition for rulemaking would allow any iphysiciantousetheradioactivedrugwithouthavingbasic. training'and- e
' experience in the. safe use.of radioactive drugs.
~
NRC's regulatory responsibilities' for the medical- uses of radioactive drugs
' ^ include cons.deration' of both.(1) the_ safety of patients, medical care
. providers...and the public and (2) the environmental _-impacts of the use of radioactive drugs. In fulfilling these responsibilities, the're are several steps being followed in reviewing the petition to ensure that all concerns are R- identified and resolved. ;
One step was-publishing a " Notice of receipt-of petition for rulemaking" in -
the: Federal Reaister. The NRC received a large number.of comments supporting the petition.- Another step the' NRC took in resolving this petition wa.
econsulting with its Advisory Committee on the Medical Uses of Isotopes
- (ACMUI). In the letter you enclosed from Tri-Med, dated December 28,.1995, xTri-Med expressed concerns that "... a' hearing was held in October, 1995-
-without-any dissenting opinions...." and that-the NRC is holding up approval of a "' waiver' or an ' exemption' so that physicians may-use this safe radiopharmaceutical .for~ the diagnosis of' this . disease." 'I ~ assume that the -
'" hearing" referred to in Tri-Med's letter w .s the semiannual._ ACMUI meeting I
' held'on-October 18.and 19,.1995.. The ACMUI supported the petition and NRC 9
O will consider its recommendation in the resolution of the petition. However, I
the NRC staff must. independently develop-the regulatory basis-for. granting the
. petition.-
1
- InLmeeting its responsibilities-under the National Environmental Policy Act. -l
> ;the NRC is required to-perform an~ environmental assessment. This assessment a lis being perfomed toidetermine whether the increusental-increase of c.arbon-14 l
'in the environment, from the widespread use of this radioactive drug by
- ~ (physiciansinot trained in the safe use of radioisotopes,- represents a
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L, e The Honorable Jan Meyers 2 significant environmental impact. If the environmental assessment and other analyses support ^the petition, the NRC will proceed to rulemaking. Concurrent ,
with NRC's assessment, this product is undergoing a similar review by the FDA.
NRC intends to resnive this issue in a time frame consistent with FDA approval, so that the product is made available as soon as practical.
The Administrative Procedure Act requires that the NRC publish a proposed rule, *'ith erablic comment period, and a final rule in the Federal Recister.
A proposed rule would be published shortly after the completion of the .
aforerentioned analyses. At the close of the public comment period, the .
comments would be analyzed And a decision would be made at that time on whether to proceed with publication of a final rule granting the petition.
Let me assure you that the NRC staff will continue working toward resolving the petition. We expect to resolve this petition in 1996.
Sincerely, OriginalsWW p 3. Taylor James M. Taylor Executive Director for Operations Distribution:
JEGlenn/RPHEB rf JPiccone RES File ASummerour, RES No. 960012 TSpets JMilhoan, EDO FCostanzi HThompson, ED0 DCool JBlaha, ED0 FCombs MBridgers, EDO No. 963 LCamper SECY 96-0037 Document name: [g:\ jones \960012]
To receive a copy of this doevant, Indicate in the box "Cu a copy without attachment / enclosure, "B" = copy with attachment / enclosure, "Nu a No copy PDR Yes/No FC
- See previous concurrence OFFICE RPHEB:DR A ' DRA:RES ADM R?HEB:DRA DRA:RES NAME *SJones. ' ABeranek 'MLesar "JGlenn 'BMorris DATE 2nM6 2046 2n#6 2nS6 2nS6 g g [*.eINo.. .. o. . .
es OFFICE D:RES 00C t00 s / EDp / OCA y NAME 'DMorrison
- STreby HThor n JT lor DRs h u DATE 2/8/96 2n/96 b /M /96 p/ *yf96 ')Jh6 DIST Yes/No Yes/No Yes/No Yes/No Yes/No 0 ;HCIAL RECORD COPY RES FILES CODE No.: _
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January 16, 1996 1133 W. 95tn $rau1. SwTs 217 OvtetaNo Pann, KS 66212
@13> 30H013 Mr. Ivan Selin Chairman U.S. Nuclear Regulatory Commission Washington, D.C. 20555
Dear Mr. Selin:
Please find enclosed a copy of the letter I received from my constituent, Mr. W.A. Fry, expressing concern about the length of time involved in reviewing the safety of a radioactive isotope necessary for diagnostic testing.
I would like to have your comments about the concerns raised by Mr. Fry. Your reply will be very helpful to me in responding _
to my constituent.
Thank you for your attention to this request. I look forward to hearing from you.
S cerel an Meyers Member of Congress mj Enclosure ,
x n5md %,,, ay,p u a v ,
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16309 WEST 108th CIRCLE LENEXA, KS 66219 December 28, 1995 ph'58 i so i
The Honorable Jan Meyers 2303 Rayburn House Office Building Washington, D.C. 20515
Dear Representative Meyers:
I am writing to you on behalf of the organization that I chair, Tri-Med Specialties, Inc. We are a small medical device distrib-utor and manufacturer located in Lenexa, Kansas. Since early in 1987, we have been actively involved in presenting the theory that ulcer disease is caused by a bacteria, Helicobacter pylori, instead of stress and excess acid. Our association includes Dr.
Barry J. Marshall, the Australian physician who lives in Virginia and who isolated this bacteria. We have marketed a product since November, 1988 that diagnosis H. pylori. This test has brought the cost of diagnosing this bacteria from approximately $150.00 to $250.00 to a fee of between $5.00 and $20.00. This product is now a part of what the FDA considers a " gold standard" for diag-nosing the bacteria.
Based on the unit sales that we have on our current test, we have saved patients an average of $500,000.00 to $800,000.00 per month in fees charged directly to them or to their insurance carrier because of this diagnostic producc. However, this product did require an expensive endoscopy procedure to produce a result.
This brings me to our current situation. We have filed for a new drug application with the FDA and intend to market another diag-nostic for this bacteria. This product would be completely non-invasive ie, a breath test. This should save the patient an average of $1,000.00 in procedural fees since an endoscopy will not be required. Again, based on the number of endoscopies that are being done annually, this particular product would be saving over $2,000,000.00 per month for the patients,. insurance carriers or medicare reimbursement.
(913) 362-7290 A (800) 874-6331 A FAX (913) 642-7418
e, F
'The Honorcblo JCn M;yars d,
December 28, 1995 E .
The FDA curre7tly has two breath tests'in front of them for-approval. One is_the Carbon 13 Breath Test that has an expected cost to the patient of between $125.00 and $250.00. The test that we have developed is the Carbon 14 Breath Test with an expected cost to the patient of between $45.00 and_S100.00. The-difference between the two tests is that our C14 test contains a radioactivt. isotope that has been declared by the NRC to be of such slight radioactivity that there is little concern. In fact, the radioactivity in our diagnostic test is less than what a patient would receive in natural sunshine in a one day period in most United States locations. However, the NRC is now weaving their way through their " administrative jungle" in order to make this product available readily for physicians to use in the '
United States. When we initially filed a request with the NRC for a waiver, they felt it would be available within twelve months of the time of our request. Publication of our request in the Fed-eral Register took place in December, 1994 and a hearing was held in October, 1995 without any dissenting opinions. However, the NRC is continuing to hold up our request for approval. For this ,
reason, we are asking your help in contacting the NRC to find why 1 the delay in approving a " waiver" or an " exemption" so that phy-sicians may use this safe radiopharmaceutical for the diagnosis of this disease.
Our business in Kansas has grown from $0.00 in 1987 to an expected annual sales of $6,000,000.00 in 1995. With this breath test, we anticipate sales in 1996 to be approximately
$25,000,000.00 and 1997 sales to be in the range of
$45,000,000.00. We currently employ 10 people in our office in Lenexa and eight people at our Virginia research and development facility. We have plans for doubling our work force as soon as approval has been granted by the FDA and NRC. We foresee 100 people in our facilities by 1998.
Most of our contact has been with Representative Dan Burton of the 6th District of Indiana. Mr. Burton had been infected with this bacteria and the bacteria har been eradicated by Dr. Mar-shall. He is knowledgeable on this subject and if you wish to have a personal contact, Mr. Burton would be more than happy to talk with you.
Thank you for taking the time to read this lengthy letter and I would never had contacted you if I did not think it was an impor-tant factor in the development of diagnostic medicine. If you should need any other information, please feel free to contact me
-- or have your staff contact me and I will be more than happy to discuss this further.
Warmest regards, Tri-Med Specialties, Inc.
)
W. A. Fry /-
President
.